Search Results

The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in an Einthoven Triangle.

It is intended for use as a diagnostic aid as part of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient.

It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds. When the device's integral electrodes are placed on the chest of the patient, it is capable of verifying the existence of cardiac biopotential activity. The quality of the biopotential activity display depends upon user technique and environmental conditions and it is in no way meant to be diagnostic.

The CADIscope is a patented electronic stethoscope with an integrated graphics display to show the amplified heart sounds as phonocardiograms and show parallel to the heart sounds the ECG in a standard Einthoven Triangle.

The provided text is a 510(k) summary for a medical device (K990809, CADIscope Electronic Stethoscope). It focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not explicitly present in the provided document. The submission relies on demonstrating that the CADIscope's performance is similar to already cleared devices through qualitative comparison.

However, I can extract information related to the device's characteristics and its comparison to predicate devices, which implicitly serve as performance benchmarks for substantial equivalence.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance

The document does not state explicit quantitative acceptance criteria for the CADIscope. Instead, the "acceptance criteria" are implied by its substantial equivalence to the predicate devices. The device's performance is reported through a comparative table highlighting its features versus the predicate devices.

Study Information (as inferable from the document)

Since this is a 510(k) substantial equivalence submission, the "study" is primarily a comparison to predicate devices rather than a standalone clinical trial with performance endpoints.

1. Sample size used for the test set and the data provenance: Not applicable in the context of a 510(k) substantial equivalence comparison. No specific test set or patient data is mentioned for performance evaluation. The comparison is based on device specifications and functionalities.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in the experimental sense is not established as part of this submission. The "ground truth" for the device design and intended use is derived from regulatory guidelines and the established capabilities of the predicate devices.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No formal adjudication process for a test set is described.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The CADIscope is an electronic stethoscope with an ECG display, not an AI-based diagnostic tool. No MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a human-operated diagnostic aid. Performance is implicitly human-in-the-loop by its nature (healthcare professionals using a stethoscope and interpreting displays).
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) substantial equivalence submission. The "ground truth" for regulatory clearance is that the device's features and safety are comparable to legally marketed predicate devices.
7. The sample size for the training set: Not applicable. This device does not use machine learning, so there is no "training set."
8. How the ground truth for the training set was established: Not applicable, as there is no training set.

In summary, the K990809 submission for the CADIscope Electronic Stethoscope relies on demonstrating substantial equivalence to existing predicate devices (Cardionics E-Scope Electronic Stethoscope and Schiller Miniscope MS-3 Electrocardiograph) rather than providing data from a dedicated performance study against explicit, quantitative acceptance criteria. The "acceptance criteria" are effectively met by showing that its intended use, technological characteristics, and performance are similar to or, in some cases, improved upon those of the predicate devices.

Ask a specific question about this device